Senior Validation Engineer - Midlands.

Position Summary

This exciting and challenging position will be responsible for supporting the validation activities within a dynamic medical device manufacturing facility. In addition, the position will be required to provide quality engineering leadership on multiple cross functional project teams.  The Sr. Validation Engineer will be responsible for providing input and critical review and approval of all validation activities  

This will include, but not be limited to: Process Validation, Software Validation, Equipment Validation, Utilities Validation, and Facilities Validation activities. Responsibilities will include reviewing, executing and summarizing protocols for processing equipment, laboratory equipment, facility systems, control systems, process validation for the manufacture of medical devices. Other responsibilities include performing quality and risk management

Principle Accountabilities:
• Use quality engineering techniques to ensure products released for distribution meet their intended performance requirements for safety and efficacy.
• Data collection, data interpretation and analysis, root cause analysis and report writing.
• Assist in the design, analysis and approval of IQ, OQ, PQ, and PV protocols and reports.
• Communicate and teach validation approach and requirements.
• Maintain master validation plans.
• Assess proposed changes to validated processes and identify the validation requirements necessary to maintain the validation status after execution of the change.
• Participate and provide assistance and technical support on technical project teams as subject matter expert on process validation regulations/procedures.
• Support technology transfer of processes.
• Critically review and provide support for validation sections of regulatory submissions where required
• Work closely with Regulatory, Operations and R&D Departments.
• Quality and risk management.
• Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Work on significant problems of diverse scope in which analysis of situations or data requires an in-depth evaluation of variables.
• Provide quality engineering support in supplier quality assessments and issues.
• Identify continuous improvements opportunities where possible and take part in improvement projects as assigned

Skills and Qualifications Sought:

Minimum Requirements:

• B.S. or M.S. in Engineering, (Preferably Chemical or Mechanical) or equivalent discipline
• 8 + years of Quality, Process Development, Process Validation, or Manufacturing engineering experience in the medical device and/or pharmaceutical industry.
• Ability to troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process or system modifications, capital projects, and technology transfer.
• Ability to function in a fast-paced, highly technical environment.
• Strong problem-solving and critical thinking skills.
• Sound understanding of engineering principles and their creative application on-the-job.
• Strong mechanical aptitude.
• Thorough knowledge of industrial process design and engineering techniques.
• Ability to understand and follow machine drawings, blueprints, and process diagrams.
• Computer skills required, with strong proficiency in Microsoft Office software. Skill with Visio is desirable.
• Excellent communication skills.
• Excellent organizational skills with ability to prioritize and work effectively on multiple tasks.
• Ability to work independently (or with minimum supervision), efficiently and be results oriented.
• Solid mentoring skills in developing less experienced engineers.
• Good numeracy skill with ability to perform statistical analyses and design experiments.
• Experience with Minitab, or other statistical software packages preferred.
• In depth knowledge of Good Manufacturing Practices GMP, Quality System Regulations and ISO quality standards.

Preferred Requirements:

Strong manufacturing experience, particularly in relation to the Quality and validation requirements of the business.
Project Management Experience
ASQC/ Green Belt/Black Belt certification preferred not required.

Previous experience with EO sterilisation would be  distinct advantage